Clinical Trials

Lost in Translation – What does it mean to be a “Qualified Investigator”?

Based on Canadian and American regulations and guidelines, research sponsors and IRB/REBs must assess the qualifications of the investigator to conduct and supervise the proposed clinical trial. Steps may include, but are not limited to, the evaluation of the investigator’s resume, reviewing relevant publications, and assessing whether they have received the proper training on the […]

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Am I IRB Forum Shopping? Case Study #4 – IRB Forum Selling

The Montreal Tuberculosis Outbreak remains the most blatant case of IRB Forum Shopping in history. The events can be summarized as follows: The Montreal Tuberculosis Outbreak remains the most blatant case of IRB Forum Shopping in history. Why did SFBC Anapharm send their fourth study to IRB Services? Could it be that SFBC Anapharm had […]

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The Montreal Tuberculosis Outbreak Revisited.

Following our March 3, 2016 post entitled “Preventing your study from becoming the next tragedy.”, we received numerous requests for information regarding the Montreal tuberculosis outbreak. This avoidable tragedy was not covered – to any great extent – by English Canadian media, which may explain why few Canadians have ever heard of it. It wasn’t […]